desgen pediatric

Generic: dextromethorphan hbr, guiafenesin, phenylephrine hcl

Labeler: kramer novis
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name desgen pediatric
Generic Name dextromethorphan hbr, guiafenesin, phenylephrine hcl
Labeler kramer novis
Dosage Form SOLUTION/ DROPS
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/mL, guaifenesin 50 mg/mL, phenylephrine hydrochloride 2.5 mg/mL

Manufacturer
Kramer Novis

Identifiers & Regulatory

Product NDC 52083-641
Product ID 52083-641_ab452649-56eb-4ca6-8e30-03cfd2bcdb2e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-01-27

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52083641
Hyphenated Format 52083-641

Supplemental Identifiers

RxCUI
1095503
UPC
0352083641015
UNII
9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name desgen pediatric (source: ndc)
Generic Name dextromethorphan hbr, guiafenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
  • 50 mg/mL
  • 2.5 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, DROPPER (52083-641-01)
source: ndc

Packages (1)

52083-641-01 30 mL in 1 BOTTLE, DROPPER (52083-641-01)

Ingredients (3)

dextromethorphan hydrobromide (5 mg/mL) guaifenesin (50 mg/mL) phenylephrine hydrochloride (2.5 mg/mL)

Linked Drug Pages (1)

Desgen Pediatric ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ab452649-56eb-4ca6-8e30-03cfd2bcdb2e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0352083641015"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1095503"], "spl_set_id": ["12425c1b-8bdc-446b-83dd-95e05a4d9b8c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Kramer Novis"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, DROPPER (52083-641-01)", "package_ndc": "52083-641-01", "marketing_start_date": "20140127"}], "brand_name": "Desgen Pediatric", "product_id": "52083-641_ab452649-56eb-4ca6-8e30-03cfd2bcdb2e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "52083-641", "generic_name": "Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl", "labeler_name": "Kramer Novis", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Desgen", "brand_name_suffix": "Pediatric", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/mL"}, {"name": "GUAIFENESIN", "strength": "50 mg/mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140127", "listing_expiration_date": "20261231"}